Software Design Assurance Engineer

BD

San Diego, CA, USA
Base: $102,000.00 - $168,200.00; bonus/equity: not...
Fully remote
Iso 13485 compliance knowledge
Iec 62304 software lifecycle expertise
Iso 14971 risk management application
This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971

Job Summary

  • This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971.
  • The engineer will partner with Quality Assurance, Compliance, and Engineering teams to align processes with secure SDLC expectations.
  • BD offers a culture that values authentic contributions, learning opportunities, and the chance to reinvent the future of health.

Matching Summary

This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971.

Salary

Base: $102,000.00 - $168,200.00; Bonus/Equity: Not specified; Benefits: Competitive package described on Careers Site

Skills & Requirements

Must-have

  • ISO 13485 compliance knowledge
  • IEC 62304 software lifecycle expertise
  • ISO 14971 risk management application
  • Secure SDLC and quality alignment
  • Test plan development and execution

Nice-to-have

  • Cybersecurity vulnerability remediation
  • Cross-functional collaboration skills
  • Root-cause analysis proficiency
  • Continuous improvement mindset
  • Defect tracking best practices

Key Requirements

  • Bachelor's Degree in Computer Science or related field
  • 3-5 years of relevant experience
  • Minimum 4 days in-office presence per week

Work Rights

Not specified

Tailored Resume

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